WO2002032438A1

WO2002032438A1 - Pharmaceutical composition treating gynecological blood stasis diseases, cardio and cerebral vascular diseases, respiratory diseases and the like

Info

Publication number: WO2002032438A1
Application number: PCT/CN2000/000273
Authority: WO
Inventors: Wei Xiao
Original assignee: Jiangsu Kanion Pharmaceutical Co.
Priority date: 2000-09-13
Filing date: 2000-09-13
Publication date: 2002-04-25
Also published as: ES2377192T3; US20030224073A1; EP1188442A2; EP1188442B1; DK1188442T3; NO20031143D0; US7052700B2; CN1455676A; US20020160059A1; US20060165721A1; US20100080822A1; AU2002223406A1; EP1188442A3; NO20031143L; WO2002032439A1; ATE532528T1; KR20030046447A; US7691387B2; US6569468B2; US8119141B2

Abstract

The present invention relates to an pharmaceutical composition treating gynecological blood stasis diseases, cardio and cerebral vascular diseases, respiratory diseases and urinary diseases. It is composed of Ramulus Cinnamomi, Radix Paeoniae Alba, Poria, Semen Persicae and Cortex Mountant Radicis at a desired weight ratio. It is divided into capsule after the processing steps including steam distillation, alcohol extraction, concentration, granulation and drying. The pharmaceutical composition of the present invention is of a meticulously designed scientific combination. It is a good drug which demonstrates various pharmacological effects, obvious curative effects for various diseases, and no toxic or side effect, good stability and absorbability.

Description

Pharmaceutical composition for treating gynecological blood stasis, cardiovascular and cerebrovascular diseases, respiratory system and other diseases

The invention relates to a pharmaceutical composition for treating gynecological blood stasis, cardiovascular and cerebrovascular diseases, respiratory diseases and the like, and more particularly, a pharmaceutical composition prepared by using Chinese herbal medicine as a raw material. Background technique

It has been pointed out in Zhang Zhongjing's "A Brief Guide to Jinkui" in the Han Dynasty that Guiji Poria has the functions of promoting blood circulation, removing blood stasis, and relieving symptoms. However, at present, there is no comprehensive study of its efficacy in Chinese medicine.

Modern medical research has shown that the occurrence of uterine fibroids, chronic pelvic inflammatory masses, and endometrial irregular exfoliated dysfunction are related to endocrine disorders in the body, decreased immune function, and metabolic disorders. This is consistent with the understanding of the traditional medicine of the motherland. Chinese medicine believes that: After women reach middle age, their physiological functions tend to decline, while menstruation and motherhood consume a lot of qi and blood. In addition, middle-aged women are prone to qi stagnation due to emotional and other factors under the dual pressure of family life and social life Stasis, imperfect meridians, impediment to stasis, and accumulation in the uterus are collectively referred to as gynecological blood stasis syndrome. Gynecological blood stasis, the motherland medicine believes that, under physiological conditions, blood circulates "like water" in the veins. "Blood circulation, disease can not be born", and when blood stasis occurs, the "blood loss", resulting in "blood coagulation but not flow", "blood can not pass" and other pathological conditions. In this regard, the medical science of the motherland uses blood circulation as a means to re-circulate impenetrable blood vessels, thereby achieving the purpose of removing blood stasis and eliminating diseases. Its treatment principle is to promote blood circulation and remove blood stasis, and to relieve the syndrome.

Currently there are hormone therapy, surgical therapy and traditional Chinese medicine for the above gynecological diseases, but the treatment effect is not satisfactory.

On the basis of the medical theory of the motherland, the inventors not only conducted research on the compatibility of components such as Guiji and Poria, but also conducted research on multifunctional efficacy. The results of the study found that the medicament composed of Guiji, Poria, Paeonia lactiflora, peach kernel and peony peel and formulated through extraction and other processes has better functions of promoting blood circulation, removing blood stasis, and alleviating symptoms, not only for treating women Department of blood stasis such as uterine fibroids, pelvic inflammatory disease, dysmenorrhea, irregular menstruation, gynecological bleeding and other diseases have obvious effects, but also found for the treatment of cardiovascular and cerebrovascular diseases such as hypertension, heart disease, respiratory diseases, Urinary system diseases, etc. also have significant effects. Disclosure of invention

Therefore, the primary object of the present invention is to provide a pharmaceutical composition for treating gynecological blood stasis, cardiovascular and cerebrovascular diseases, respiratory and urinary diseases;

Another object of the present invention is to provide the pharmaceutical composition as a medicine for treating gynecological blood stasis such as pelvic inflammatory disease, dysmenorrhea, irregular menstruation and bleeding in women;

Still another object of the present invention is to provide the use of the pharmaceutical composition as a medicament for treating cardiovascular and cerebrovascular diseases such as hypertension and heart disease;

A further object of the present invention is to provide the use of the pharmaceutical composition as a medicament for the treatment of a respiratory system disease or a urinary system disease.

The present invention relates to a pharmaceutical composition for treating gynecological blood stasis, cardiovascular and cerebrovascular diseases, respiratory system and urinary system diseases,

It is characterized in that it is a medicament made of the following raw materials in the following weight ratio and prepared by the following method

Guiji 1—2 servings Baiji 1—2 servings

Poria 1-2 servings Peach Kernel 1-2 servings

Peony skin 1-2 servings

The preparation method of the medicine includes:

First, a required amount of peony skin is taken and steam-distilled in order to extract paeonol therefrom. Refrigerate the distilled solution of the aqueous solution and filter to obtain the filtrate, which is crude paeonol. Mix the medicine residue obtained from the above filtration with the required amount of Guiji, Baiji, Tiaoren and half of Poria, and add an appropriate amount to it. The ethanol is extracted after each filtration, and the ethanol extract is obtained after each filtration. Then, the drug residue extracted with ethanol is added with an appropriate amount of water for decoction. The water extract is obtained after each filtration. The ethanol extract and the water extract are combined with the above-mentioned Distilled aqueous solution of peony skin Combine and concentrate into extracts; pulverize the remaining half of Poria to a fine powder, mix with the concentrated extract, granulate, and dry, add crude paeonol, and mix to make capsules.

The pharmaceutical composition according to the present invention is characterized in that in the preparation, the extraction with an appropriate amount of ethanol is performed with three times the amount of 90% ethanol for extraction, and the extraction is performed twice; Add the right amount of water for frying, add 4 times more water for frying, and fry

〇

o

Boil three times; the ethanol is added for extraction for 2 hours each time, and the water is added for decoction for 2 hours each time;

The invention also relates to the use of the pharmaceutical composition as a medicine for treating diseases such as uterine fibroids, pelvic inflammatory disease, dysmenorrhea, irregular menstruation, bleeding in women, etc .; the present invention also relates to the pharmaceutical composition The utility model is used as a medicine for treating cardiovascular diseases such as hypertension, heart disease, and other diseases of the respiratory system and urinary system.

The inventors have conducted a large number of animal tests and clinical practices on the pharmaceutical composition (hereinafter referred to as cinnabar capsule), and have proved that it has the effect of treating various diseases, and the effect is remarkable. The following tests are described below:

First, reduce the whole blood viscosity of rats

Male Wistar rats, weighing 250-300 g, were randomly divided into 5 groups. They were given different doses of guinea fistula and the same volume of normal saline once a day for 5 consecutive days. After a minimum of 1.5 hours after the last dose of ether anesthesia, blood was taken from the abdomen, and heparin was anticoagulated. XN-5 blood viscometer was used to measure the specific viscosity of whole blood. The results are shown in Table 1.

Table 1.Effect of Guiji Poria Capsule on Whole Blood Viscosity in Rats

Whole Blood Specific Viscosity Full Blood Specific Viscosity Drug Dosage (g / kg) Number of Animals Low-cut High-cut Saline-8 29.85 ± 9.33 12.10 ± 1.90 Cinnamon Capsule 5.0 8 17.98 ± 4.78 ^ 9.66 ± 1.47 * Cinnabar Capsule 10.0 8 16.69 ± 4.86 * 8.49 ± 1.81 ^ Cinnamon capsule 8 15.36 ± 4.38 6.68 ± 2.15 ^ Pan Shengding 0.2 8 16.12 ± 6.92 * 12.10 + 1.90 Note: Compared with the control group, * P <0.05, ** P <0.01, *** P <0.001 (the same below), the numbers in the table are all SD

The results show that administering Guizhi Capsule can significantly reduce the specific viscosity of whole blood in rats (low-cut and high-cut). Compared with the control group, the difference is significant. Second, inhibit platelet o aggregation

1. Rabbit platelet aggregation in vitro

Rabbits weighing about 2.5 kg were intubated to bleed in the common carotid artery. 3.13% sodium citrate anticoagulant. The ratio of whole blood to anticoagulant is 9: 1. PRP (platelet-rich plasma) was prepared by centrifugation at 1,000 rpm for 7 minutes, and FPP (platelet-poor plasma) was prepared after aspiration of PRP by centrifugation at 3000 rpm for 10 minutes. The test was performed using the Born method with a DC C SPA-III platelet aggregation instrument. Use different concentrations of cassia gum and prepared PRP at 37 ° C.

+1

Incubate for 10 minutes. The control group was given the same volume of saline. The final ADF concentration is lum. The experimental results are shown in Table 2.

Table 2 Effect of Guiji Fulingjiao on the aggregation of isolated platelets in rabbits Drug Concentration (mq / ml) Number Aggregation rate (%) Inhibition rate (%) Normal saline-5 67.95 ± 19.32

Guilin capsules 12.5 5 51.32 ± 11.78 ** 24.47 ± 7.76 Guilin capsules 25.0 5 39.60 ± 12.23 41.72 ± 7.96 Guilin capsules 37.5 5 62.38 ± 6.54 Guilin capsules 50.0 5 13.74 ± 5.32 ^ 79.78 ± 3.50 Guilin capsules 5 95.33 ± 1.46 Aspirin 0.3 5 57.28 ± 1.68

Saline a 5

The experimental results show that Guicao capsule can inhibit ADP (adenosine diphosphate) -induced platelet aggregation in rabbits, and its inhibitory effect is positively correlated with dose. Aspirin Forest inhibition is obvious. Calculated Guisong capsule IC ₅ . = 25.12mg / ml.

2. Rat in vivo platelet aggregation test

Male Witar rats were weighed 250-300g and randomly divided into 5 groups. Cinnamon gum capsules were administered at different doses. The control group was given the same volume of saline. Once a day for 5 consecutive days. 1.5 hours after the last dose of anesthesia with mild ether, blood was taken from the abdominal aorta, and 3.13% sodium citrate was used for anticoagulation. The positive drug was given once to aspirin, and rat platelet plasma was prepared in the same way as in the previous method for aggregation experiments. The results are shown in Table 3.

The experimental results show that the rats can significantly inhibit the aggregation of blood platelets induced by ADP, and the effect of increasing the dose can be enhanced after oral administration of Guicao capsule.

Table 3 Effects of Guiji Fuling Capsules on platelet aggregation in rats Drug dose (g / kg) Number of animals Aggregation rate (%) Physiological saline-7 65.33 + 11.05 Guishen limbs 5.0 7 56.19 + 7.70 Guishen capsules 10.0 7 51.78 ± 9.68 * Cinnamon capsule 20.0 7 44.86 ± 7.99 "^ Aspirin 0.1 6 26.58 ± 10.58 ** III. Diastolic rat uterine smooth muscle

Take female rats weighing 200 ± 10g, and intramuscularly inject 1mg / Kg of xylylene estradiol the day before the experiment. During the experiment, the rats were sacrificed by cervical dislocation, the uterus was quickly removed by laparotomy, and immediately placed in a device containing Rockwell fluid. Separate and remove the fat and connective tissue around the uterine wall, take about 15mm of uterine horn on both sides, and suspend it in a bath containing 10ml of Rockwell's solution at a temperature of 32 ± 0.5 ° C. Oxygen-containing gas into a 5% _(02, static tension of lg at a concentration of oxytocin vasoconstrictor 10- ³ u / ml, see the following Table 4: Table 4 Inhibitory effect of Guiji Fulingjiao on uterine contraction induced by oxytocin in rats

The above Table 4 illustrates the inhibitory effect of Guiji Fulingjiao on 10_ ³ u / ml oxytocin-induced uterine contraction in rats.

The results showed that Guizhi capsule could inhibit uterine contraction caused by oxytocin, and its half inhibitory concentration was 7.92 ± 0.49 (mg / ml).

Fourth, analgesic effect

Acetate twist method

Kunming mice were selected and weighed 18-22 g. They were randomly divided into 5 groups of 10 mice each, and the Guizhi capsules were administered with 2.5, 5.0 and 10.0 g / kg. Controlled with normal saline, the positive drug aminopyrine, was injected intraperitoneally with 0.8% acetic acid 0.1ml / l0g 1 hour after administration. Observe the number of writhings produced by the mouse in 0-10 minutes, 10-20 minutes. The results are shown in the table

5.

Table 5 Effect of Guiji Fulingjiao on mice writhing response induced by 0.8% acetic acid Drug dose (g / kg) Number of animals Route of administration Number of writhing Number of writhing Number of writhing

0-10 minutes 10-20 minutes 0-20 minutes control-10 P.0 22.7 ± 4. 23.6 ± 6.6 46.3 ± 7.3 Guiying capsules 2.5 10 P.0 19.3 ± 2.5 * 19.1 + 6.6 38.4 ± 5.4 ^A嚢 5.0 10 P.0 14.0 ± 6. (^ 12.9 ± 6.6 ^ 26.9 ± 11.7 * Aminopyrine 10.0 10 P.0 10.8 + 6.6 *** 9.6 ± 7.3 *** 20.4 ± 13.6 * Aminopyrine 0.1 10 P .0 2.8 ± 4.1 * The experimental results show that 2.5 g / Kg of cassia gum capsules can reduce the number of twists in mice The inhibition rate was 17% 41.9% 55.9% (2.5 5.0 lO.Og / Kg) at 0-20 minutes, which was significantly different from the control group. The positive drug aminopyrine has a significant effect.

2. Mouse tail flick

o

Kunming mice, weighing 18-22 g, were immersed 1/3 of their tails in a 55 ± 0.5 ° C constant temperature water bath before administration, and recorded their shaking time. They were divided into 8 groups according to the pain threshold and weight, each group 10 Only, different doses of the drug, saline, and positive drug indomethacin were administered. Record the tail flick time of 1 2 4 hours after administration. The results are shown in Table 6.

The results showed that oral administration of 10 20g / Kg Guizhou extract can prolong tail flick time in mice.

Table 6 Effect of Guizangjiao capsules on tail flick time in mice Grade flick time (g / kg) Number of animals Before administration After administration After administration After administration After administration

60 (minutes) 120 (minutes) 240 (minutes) Control group-10 1 · 58 ± 0 · 43 1.49 ± 0.4 1.57 ± 0.38 1.54 ± 0.41 Guisong capsule 5 10 1 • 56 ± 0.40 1.71 ± 0.37 1.91 ± 0.58 1.89 ± 0.66 Guiwei Capsules 10 10 1 · 55 ± 0.46 2.21 ± 0.93 ^Α 2.42 ± 0.95 ** 2.70 ± 0.92 *** Cinnamon capsule 20 10 1 .50 + 0.47 2.57 ± 0,95 ^ 2.61 ± 1 · 27 2.50 ± 0.43 indomethacin 10 1 .58 ± 0.79 2.23 ± 0.53 * 2.56 ± 0.40 1.52 ± 0.56 Note: Comparison before and after itself ΡΟ.05 ** P <0.01 *** P <0.001 (the same below) V. Anti-inflammatory effect (small Mouse ear swelling method)

Kunming mice were selected, weighing 20-25 g, randomly divided into groups according to body weight, and orally administered drugs of different doses for three days. At the same time of the last administration, the mouse ears were coated with an inflammatory agent (containing 2% croton oil, 20% absolute ethanol, 5% distilled water, and 73% ether), and applied to the front and back sides of the left ear. The animals were sacrificed 2 hours after the application, and the ear pieces of the same part of both ears were weighed with a 9mm punch. The left ear piece was subtracted from the right ear piece to obtain the swelling degree. The control group and the swelling degree were statistically processed. . The experimental results are shown in Table 7.

The results showed that oral administration of 10 20g / Kg Guizang extract to mice had obvious anti-inflammatory effects, and the effect of increasing the dose was enhanced. Table 的 Effect of Guicao capsule on ear ears in mice

Group dose (g / Kg) Average number of animals swelling (mg) Control group-10 18.36 ± 7 · 09 Guiying capsule 5 10 17.75 + 4.81 Guiying capsule 10 10 9.05 + 5.92 ** Guiying capsule 20 10 5.92+ 3.11 *** Hydrocortisone 0.025 10 4.68 ± 3.43 *** The pharmaceutical composition of the present invention can be taken in the form of a capsule, and the dosage is generally 40 to 42 mg per kilogram of body weight per day, divided into three doses.

The acute toxicity test showed that the mice were given Guizhi capsules 250g / kg orally (maximum gastric gavage capacity) after 7 days of observation. None of them died, and there were no obvious abnormalities, indicating oral LD ₅ . Above 250g / Kg. The tube of the drawings is to be explained

FIG. 1 is a process flow chart for preparing a pharmaceutical composition of the present invention;

Figure 2 is the HPLC graphic of Test Solution I-Figure 3 is the HFLC graphic of Test Solution II;

Figure 4 is an HPLC chart of paeonol reference substance;

Figure 5 is an HPLC chart of a chloroform solvent;

Figure 6 is an HPLC chart of a methanol solvent;

Figure 7 is an HPLC chart of a paeoniflorin reference.

Use the following methods to formulate the fingerprint of Guizhi Poria

(I) Instruments and reagents

US ALLtech HPLC only; ALLtech WIS-201 Zixibu visible detector; ALLtech 426HPLC pump 7725Ϊ injection valve; 10μί loop; Chromtek chromatography workstation; chromatographic column: ALLtimaC ₁₈ ^ i 5μπι, 4.6x250 wake up. Methanol (chromatographically pure, produced by Shanghai Ludu Industrial Co., Ltd., batch number: 990402); n-butanol (analytical grade, produced by Shanghai Xingda Chemical Reagent Factory, batch number 970801); chloroform (analytical grade, produced by Xuzhou Reagent Second Factory, batch number: 9901202); paeoniflorin reference substance (for content determination, China National Institute of Pharmaceutical and Biological Products, batch number: 0736-991 ² ); paeonol reference substance (for content determination, China National Institute of Pharmaceutical and Biological Products: 0708-9704); Water is re-distilled.

(2) Preparation of reference solution

Paeoniflorin reference solution: Take an appropriate amount of paeoniflorin reference and accurately weigh it. Dissolve and dilute with methanol to make a stock solution containing 0.9 mg of reference substance in each ml, and dilute it to a solution of 18.0 μm / m1.

Paeonol reference solution: Take an appropriate amount of paeonol reference and accurately weigh it. Dissolve and dilute with methanol to prepare a reference stock solution containing 0.3mg per ml, and dilute to a 6.0μ _§ / ιη1 solution when used.

(3) Preparation of test solution:

Take about 0.5g of this product, accurately weigh, add 20ml of water, and disperse by sonication for about 10 minutes. Place in a separatory funnel and extract five times with chloroform, each time 30! Nl. Combine the chloroform extracts to obtain solution A. Vortex A to a suitable amount on a 70 ° C water bath, transfer to a 50ml volumetric flask, and make up to volume with chloroform; precisely draw 5ml, place in a 50ml volumetric flask, make up to volume with chloroform, shake well, and use a 0.45μιη microporous filter membrane After filtration, the test solution I was obtained. The remaining aqueous layer was extracted with water-saturated n-butanol five times, each time 30ml. The n-butanol extracts were combined, transferred into a 200ml volumetric flask, and the volume was adjusted with water-saturated n-butanol to obtain solution B. Pipet 50ml from B liquid, dry in a water bath, dissolve the residue in methanol, transfer to a 25ml volumetric flask, and make up the volume with methanol; take 5ml precisely, place in a 25ml volumetric flask, make up to volume with methanol, shake, and use 0. The 45 μm emblem filter was filtered to obtain the test solution Π.

(IV) Chromatographic conditions and system adaptability tests:

Determination Paeonol (test solution the I): methanol: water ^(60: 40) as mobile phase; Column temperature: room temperature; detecting wavelength: 274nm. The number of theoretical plates is calculated based on paeonol. Should be no less than 5000.

Determination of paeoniflorin content (test solution II): methanol: water (35: 65) is the mobile phase; column temperature: room temperature; detection wavelength: 230nm. The number of theoretical plates is calculated based on paeoniflorin and should not be less than 1500.

(5) Measurement method

The reference solution and the test solution were each sucked ΙΟμΙ ^, and injected into high-performance liquid chromatography. The peak area was measured and calculated.

Each product contains paeoniflorin (C ^ E ^ Ou) and paeonol (C ₉ H _{1 ()} 0 ₃ ) based on the dry product, which are 3.90 ~ 5.90mg and 2.20 ~ 3.30mg, respectively. For peaks eight, B, D, and E of unknown components (see the HPLC spectra of test solutions I and II), the Z value of each particle based on the dried product should be 2.90 to 4.34, 3.46 to 5.20, respectively. 6.66 to: L0.00, 2.17 to 3.26. among them:

Ax03l

~ Mx (lW) xl0 ⁴

In the formula: A: peak area; M: sample weight (g); W: percentage of water in the sample. For specific fingerprints, see the attached figure.

In Figure 2: A and B represent unknown component peaks; C is paeonol peak.

Channel Result 00 B

Peak number Retention time Peak area Peak area% N R P

1 3.283 63507 13.128 5560.561 0 .000 1 .360

2 4.143 39890 8.246 3245.805 3 .683 1 .061

3 4.730 8454 1.748 938.556 1 .292 0 .708

4 6.870 15862 3.279 755.672 2 .646 0

5 9.133 8910 1.842 4001.684 2 .870 0 .901

6 10.073 60151 12.435 16762.576 2 .115 0 .000

7 13.993 286969 59.323 11840.265 9 .496 1 .213 In Figure 3: D and E are unknown component peaks; F is paeoniflorin peak.

Channel B results

Peak number Guaranteed 0 0 Retention time Peak area Peak area% N R P

1 2.890 86739 19.515 3769.451 0. 000 1. .058

2 3.970 125628 28.265 1492.903 3. 604 0 .954

3 5.187 10025 2.256 985.817 2. 270 0 .959

4 6.210 1525 0.343 5717.344 2. 069 0 .750

5 6.700 3939 0.886 2969.586 1. 195 0 .949

6 46518 10.466 2130.110 3. 225 0 .734 o

7 9.860 3636 0 0 698474.000 2. 982 1 .764 '

8 10.567 1534 0.345 16071.882 4. 039 0 .815

9 11.167 8721 1.962 6556.487 1. 356 1 .113

10 13.027 143698 32.330 4002.113 2.705 0.853

11 15.340 12506 2.814 0.000 0. 000 0 .000

Result B in Figure 4

Peak number Retention time Peak area Peak area% N R P

1 13.500 20 668 110 0.000

0 .000 1 .211

Channel B results in Figure 6

Peak number Retention time Peak area Peak area% N R P

1 2.623 3287 6.325 2338.630 0. 000 1 • 295

2 2.930 48684 93.675 2754.648 1. 393 1 .450

Result B in Figure 7

Peak number Retention time Peak area Peak area% N R P

1 2.590 2761 1.008 1715.138 0. 000 1 .500

2 2.923 39605 14.463 3296.563 1.469 1 .611

3 14.367 231466 84.528 4576.988 21 .733 0 .913 The best way to implement the invention

The following examples further illustrate the present invention.

First, 144Kg of peony peel was taken and steam-distilled to extract paeonol from the peony. The aqueous extract after distillation refrigerated and filtered to give filtrate, which is a crude Paeonol; peony, 144K _g Poria pick Ren 72kg mixing 144 kg of the filter and the resulting dregs Gui TECHNOLOGY, 144 kg, was added thereto in an amount of 3 times 90% ethanol was refluxed twice, and each reflux was extracted for 2 hours. After each filtration, an ethanol extract was obtained, and then the drug residue extracted with ethanol was decoated 3 times with 4 times the amount of water for 3 hours each time. Extraction after filtration ... The ethanol extract and the water extract are combined with the above-mentioned peony skin distilled aqueous solution and concentrated into an extract, which is concentrated to a relative density of 1.27 or more at 75 ~ 80 ° C to obtain about 120 kg of extract; One half of 72 kg of Poria is pulverized into a fine powder, mixed with the concentrated extract, granulated and dried, and then the aforementioned crude paeonol is added and mixed to make a capsule. The medicines prepared as above can be made into 10,000 boxes with 60 capsules per box. Industrial applicability

The pharmaceutical composition according to the present invention is closely compatible and has strong scientificity. In the long-term practice, the treatment scope of this prescription has been continuously expanded, and it is now applicable to uterine fibroids, rupture of tubal pregnancy vibration, infertility, menstrual disease, 'gynecological blood stasis, pelvic inflammatory disease, and hypertension of the cardio-cerebral system in gynecological diseases. With Meniere's disease, hypertension with hemorrhoids, heart disease, and brain ringing; paranasal sinusitis, rhinitis, asthma, vocal cord polyps in the respiratory system; urinary retention in the urinary system, back pain, and prostatitis. There are more than 20 diseases such as goiter, Bantt's disease, and adhesive intestinal obstruction, all of which have achieved satisfactory results.

In addition, the pharmaceutical composition of the present invention has the following effects in pharmacology: it has an effect on hemorheology, and can reduce the whole blood specific viscosity, the plasma specific viscosity, and the concentration of fibrinogen. Can significantly reduce the red blood cell electrophoresis time;

Preventive effect on experimental diffuse intravascular coagulation;

It has a therapeutic effect on hormone-induced stasis; Improve the peripheral circulation;

Reveals many aspects of repairing the whole body.

Therefore, the pharmaceutical composition of the present invention is a good medicine that can treat a variety of diseases, has obvious curative effects, has no toxic and side effects, has good stability, is convenient to take, and is easy to absorb.

Claims

Profit requirements

1. A pharmaceutical composition for treating gynecological blood stasis, cardiovascular and cerebrovascular diseases, respiratory diseases and urinary diseases,

It is characterized in that it is a medicament made by the following weight ratio of raw materials and prepared by the following method: Guizhi 1-2 parts Baiji 1-2 parts

Poria 1-2 servings Pickling 1-2 servings

Peony skin 1-2 servings

The preparation method of the medicine includes:

First, take the required amount of peony peel and steam-distill it to extract paeonol from it. Refrigerate and filter the extract from the aqueous solution to obtain the filtrate, which is the crude paeonol. Mix the medicine residue obtained from the filtration with the required amount of Guiji, Baiji, Tiaoren, and half of Poria. An appropriate amount of ethanol is extracted, and an ethanol extract is obtained after each filtration, and then an appropriate amount of water is added to the dregs extracted with ethanol to decoction. A water extract is obtained after each filtration. The distilled aqueous solution of peony peel was combined and concentrated into an extract; the remaining half of the amount of Poria was crushed into a fine powder, and then mixed with the concentrated extract, granulated, dried, and then the crude paeonol was added and mixed. After being homogenized, it is made into a capsule.

2. The pharmaceutical composition according to claim 1,

It is characterized in that, in the preparation method, the extraction with an appropriate amount of ethanol is performed with 3 times the amount of 90% ethanol for extraction; the added with an appropriate amount of water for decoction is 4 times with water for decoction.

3. The pharmaceutical composition according to claim 2,

It is characterized in that, in the preparation method, the extraction with ethanol is performed twice for extraction, and the addition of water for decoction is performed for three times.

4. The pharmaceutical composition according to claim 3,

It is characterized in that in the preparation method, ethanol is added for extraction for 2 hours each time, Said adding water for decoction for 2 hours each time.

5. The use of the pharmaceutical composition according to any one of claims 1 to 4,

It is characterized in that it is used for preparing a medicine for treating gynecological blood stasis.

6. In accordance with the uses described in claim 5,

It is characterized in that the medicine for preparing gynecological blood stasis is preparing medicine for treating uterine fibroids.

7-for the purposes described in claim 5,

It is characterized in that the medicine for preparing gynecological blood stasis is preparing medicine for treating pelvic inflammatory disease. '

8. The use according to claim 5,

It is characterized in that the medicine for preparing gynecological blood stasis is preparing medicine for treating dysmenorrhea.

9. Use according to claim 5,

It is characterized in that the medicine for preparing gynecological blood stasis is preparing medicine for treating irregular menstruation.

10. Use according to claim 5,

It is characterized in that the medicine for preparing gynecological blood stasis is preparing medicine for treating hemorrhage in women.

11. Use of the pharmaceutical composition according to any one of claims 1 to 4,

It is characterized in that it is used for preparing a medicine for treating cardiovascular and cerebrovascular diseases.

12. Use of the pharmaceutical composition according to claim 11,

It is characterized in that the medicine for treating cardiovascular and cerebrovascular diseases is a medicine for treating high blood pressure.

12. Use of the pharmaceutical composition according to claim 11,

It is characterized in that the medicine for treating cardio-cerebrovascular diseases is a medicine for treating heart diseases.

14. The use of the pharmaceutical composition according to any one of claims 1 to 4, It is characterized in that it is used for preparing medicine for treating respiratory diseases.

15. The use of the pharmaceutical composition according to any one of claims 1 to 4, characterized in that it is used for preparing a medicament for treating a urinary system disease.